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NCT05762107 · ClinicalTrials.gov registry record · Phase 2
A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
A Phase 2 study of Type 1 Diabetes Mellitus With Hypoglycemia, sponsored by Zucara Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 186
- Enrollment target
- 20
- Study locations
NCT05762107 is a Phase 2 study of Type 1 Diabetes Mellitus With Hypoglycemia that is actively recruiting participants, run by Zucara Therapeutics. The registered enrollment target is 186 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT05762107, a Phase 2 study of Type 1 Diabetes Mellitus With Hypoglycemia, is actively recruiting participants, sponsored by Zucara Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 186 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical trial is to learn about the effect of the study drug (ZT-01) on low blood sugar (hypoglycemia) in adults with type 1 diabetes (T1D) who have been having low blood sugars ("hypos") at night. ZT-01 increases the amount of a hormone called glucagon during low blood sugar, and this may help prevent the occurrence of hypos. The main questions this trial aims to answer are whether ZT-01 lowers the number of hypos happening at night, and what its effects are on blood sugar levels. The safety of ZT-01 will also be measured. Participants will be asked to wear a study-provided continuous glucose monitor (CGM) during two 4-week periods when they will self-inject the study drug before bed. They will get ZT-01 at one of three dose levels during one period, and placebo (which looks like the study drug but doesn't contain the active ingredient) during the other. Neither the participant nor the study site will know what they are receiving during each treatment period or see data from the CGM. The participant will continue to use their usual methods of measuring blood sugar (including their personal CGM) and giving insulin during the study. The participant will be asked to complete a short diary each evening, and will be asked to upload the CGM data to a study phone every day. If a participant uses their own CGM and is willing to share information on how often they have low blood sugar with the study site at the first visit to see if they meet study entry requirements, they will have 6 study visits, 2 study phone calls, and be in the study for about 16 weeks. If they don't use CGM or don't want to share their information, then they will be asked to wear a study CGM for an extra 4 weeks to find out how many low blood sugars they have, and will have an extra visit. Study participants will be asked to give blood and urine for testing to see whether they meet the requirements to enter the study, and at the start and end of each treatment period to see if the
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ZT-01, 7 mg
- DRUG ZT-01, 15 mg
- DRUG ZT-01, 22 mg
Study Locations (20)
Florida
- East Coast Institute for Research LLC - Jacksonville
- Suncoast Clinical Research - New Port Richey
- Hanson Diabetes Center - Port Charlotte
- Metabolic Research Institute - West Palm Beach
California
- Headlands Research - Escondido
- USC Keck Medicine Eastside Center for Diabetes - Los Angeles
- LCGK Research - San Carlos
Georgia
- Atlanta Diabetes Associates - Atlanta
- Physicians Research Associates LLC - Lawrenceville
- East Coast Institute for Research - Macon
Maryland
- Baltimore VA Medical Center - Baltimore
- MedStar Good Samaritan Hospital - Baltimore
New York
- Albany Medical Center - Albany
- NYC Research Inc. - Long Island City
Indiana
- IU Health University Hospital - Indianapolis
Kansas
- University of Kansas Medical Center - Kansas City
Michigan
- Elite Research Center - Flint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2023-07-28 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05762107
The ClinicalTrials.gov registry entry for NCT05762107 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zucara Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes Mellitus With Hypoglycemia appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05762107 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05762107 about?
NCT05762107 is a clinical study titled "A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes". The goal of this clinical trial is to learn about the effect of the study drug (ZT-01) on low blood sugar (hypoglycemia) in adults with type 1 diabetes (T1D) who have been having low blood sugars ("hypos") at night. ZT-01 increases the amount of a hormone called glucagon during low blood sugar, and ...
What is the current status of trial NCT05762107?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 186 participants. The study started on 2023-07-28. Estimated completion is 2027-05.
What conditions does trial NCT05762107 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus With Hypoglycemia.
What interventions are being tested in trial NCT05762107?
The interventions under investigation include: Placebo (DRUG), ZT-01, 7 mg (DRUG), ZT-01, 15 mg (DRUG), ZT-01, 22 mg (DRUG).
Who is sponsoring clinical trial NCT05762107?
This trial is sponsored by Zucara Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05762107 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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